Study of Lopinavir/Ritonavir Tablets Comparing Once-Daily Versus Twice-Daily Administration When Coadministered With Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-Experienced Human Immunodeficiency Virus Type 1 Infected Subjects
Completed · Phase 3
Conditions studied: Human Immunodeficiency Virus Infections
In brief
The purpose of this study was to compare the safety, tolerability, and antiviral activity of once-daily (QD) and twice-daily (BID) dosing of the lopinavir/ritonavir (LPV/r) tablet formulation in combination with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) in antiretroviral-experienced human immunodeficiency virus type 1 infected subjects with detectable viral load while receiving their current antiretroviral therapy.
Key facts
- Study ID
- NCT00358917
- Run by
- Abbott
- People needed
- 599
- Starts
- 2006-08-01
- Expected to finish
- 2008-11-01
- Last updated by the study team
- 2011-04-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects were human immunodeficiency virus type 1 (HIV-1) positive, antiretroviral-experienced adults at least 18 years of age currently receiving an antiretroviral regimen which had not changed for at least 12 weeks.
- Subjects had plasma HIV-1 ribonucleic acid (RNA) levels > 1,000 copies/mL at screening and were not acutely ill.
- Subject was currently failing his/her antiretroviral regimen with the most recent 2 consecutive prestudy plasma HIV-1 RNA levels > 400 copies/mL with the most recent being > 1000 copies/mL, and in the investigator's opinion, should change therapy
- Female subjects were nonpregnant and nonlactating.
You may not qualify if…
- Subjects were excluded if screening laboratory analyses showed hemoglobin <= 8.0 grams per deciliter.
- Subjects were excluded if screening laboratory analyses showed absolute neutrophil count <= 750 cells/microliter.
- Subjects were excluded if screening laboratory analyses showed platelet count <= 50,000 per cubic millimeter.
- Subjects were excluded if screening laboratory analyses showed alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 5.0 x upper limit of normal (ULN).
Where it is running
- Medical Information - Abbott (1-800-633-9110) — Abbott Park, Illinois, United States
Full record on ClinicalTrials.gov
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